For Natural Health Product Enhancement
Design lean, fit-for-purpose studies that are powerful enough to upgrade or expand Natural Health Product (NHP) claims—without “drug-sized” budgets.
Translate business goals into claim types (e.g., helps to, structure/function, risk-reduction) and map the minimum adequate evidence to substantiate each claim.
Pragmatic RCTs, crossover or n-of-1 series, add-on designs, use-as-directed studies, and observational/RWE approaches when appropriate.
Validated PROs, functional outcomes, and practical biomarkers aligned to the intended label text and advertising standards.
Sample size tied to minimally important differences; simple analyses with pre-specified SAP to keep studies efficient and credible.
Decentralized/remote elements, eConsent, ePRO, and streamlined monitoring for minimal-risk studies.
REB-ready protocols, informed consent, and evidence packages aligned to Canadian expectations for NHPs—positioned for label updates and promotional substantiation.
GCP-lite governance proportional to risk, with TMF/eTMF, data integrity, and PV/AE capture sized for self-care products.
Outcome: credible, defensible claims—at a cost and timeline that makes sense for self-care brands.
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